1. LOGOLOGO ASEANREGISTRATION OF ANIMAL VACCINES Presented by: MARI A V. ABEN ES, RMT, DVM, MM Officer- I n- Charge Anim al Feeds, Veterinary Drugs and Biologics Control Division, Bureau of Anim al I ndustry Departm ent of Agriculture Quezon City, Philippines

2. 1.Registration Procedures 2.Sample Supply and Testing in ASEAN Accredited Animal Vaccine Testing Laboratory 3.Determination of Registration Code or Number 4.Renewal of Registration Mechanism of ASEAN Registration of Animal Vaccines

3. Stages of Document Evaluation Submission of complete application and registration documents to ASEAN Secretariat for circulation to 9 member states through the National Focal Points Acknowledgement of receipt of documents Evaluation of documents within 2 months

4. Stages of Document Evaluation Consolidation of comments by National Focal Point of applying country Submission ofVaccine Samples for laboratory testing Submission of additional data

5. Registration Procedures Registration Fee Payment Preparation and Submission of Registration Documents Document Evaluation

6. Stages of Preparation and Submissio n of Registration Documents Application forms are available at the ASEAN National Focal Points for Veterinary Products or at the Animal Vaccine Authority of ASEAN Member States. Submission of application forms and registration documents (Vaccine Dossier) to the National Focal Point of ASEAN Member States where the applicant applies for preliminary evaluation

7. Sample Supply and Testing in the l a b o r a t o r y 1.Submission of vaccine samples at designated ASEAN accredited animal vaccine testing laboratory 2.Payment of testing fee 3.Issuance of Certificate of Analysis if vaccine meets requirements 4.Submission of new batch of vaccine if declared “unsatisfactory serial”

8. Issuance of Registration Number with validity of 5 years and renewable every 10 years

9. ISSUES AND CONCERNS Certifying Body? National and Internal Policy of ASEAN Member States

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